BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 9246202 · Received October 28, 2019

    Report

    Report Number
    2937457-2019-03264
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    September 19, 2019
    Report Date
    October 28, 2019
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN EXTERIOR VISUAL INSPECTION OF THE RETURNED CYCLER SHOWED NO SIGNS OF PHYSICAL DAMAGE. UPON POWER UP, THE CYCLER TOUCH SCREEN TEST FAILED. WHEN POWERING ON THE CYCLER, THE OK, STOP AND UP/DOWN ARROW PUSH BUTTONS ILLUMINATED, HOWEVER THE FRONT PANEL TOUCH SCREEN REMAINED BLANK. AN INTERNAL INSPECTION OF THE CYCLER FOUND EVIDENCE OF AN INTERNAL SHORT PRESENT ON TRANSFORMER (T1) OF THE INVERTER BOARD. THE INVERTER BOARD IS LOCATED ON THE REAR OF THE FRONT PANEL ASSEMBLY. A KNOWN GOOD INVERTER BOARD WAS INSTALLED, AND THE TOUCH SCREEN BECAME OPERATIONAL. REMOVED FUNCTIONING INVERTER BOARD FROM THE TOUCH SCREEN AT THE COMPLETION OF THE INVESTIGATION. CYCLER REVEALED DRIED FLUID UNDER THE PUMP ASSEMBLY ON THE BOTTOM COVER. THE CAUSE OF THE OBSERVED DRIED FLUID COULD NOT BE DETERMINED. AN INVESTIGATION OF THE CYCLER MUSHROOM HEADS VERIFIED THAT THE SURFACE CONDITIONS AND ALIGNMENTS WERE WITHIN SPECIFICATION. THE CYCLER TESTED NEGATIVE FOR GLUCOSE. AN INTERNAL VISUAL INSPECTION OF THE RETURNED CYCLER ENCOUNTERED NO OTHER DISCREPANCIES. A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DID REVEAL TEST AND CALIBRATION: STEP 5.4 NO DISPLAY. CYCLER SENT TO REWORK. JD 11/30/18 REWORK: PER REWORK MANUAL P/N 509272, REVISION Q PAGE 113 FOUND OUT DETECTIVE DISPLAY. REPLACED FRONT PANEL. SEND MACHINE BACK TO TEST AND CALIBRATION LINE. SS 11/30/18. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND VERIFIED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN OF A PATIENT¿S LIBERTY SELECT CYCLER WENT BLANK DURING THEIR PERITONEAL DIALYSIS (PD) TREATMENT. THE PATIENT REBOOTED THAT THE CYCLER AND ALARMED WITH A SENSOR MESSAGE. THE CYCLER WAS PROPERLY PLUGGED. THE OK AND STOP KEYS WERE ON, HOWEVER THE SCREEN REMAINED BLANK. AT THAT POINT IN TIME, THE TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE PATIENT TO DISCONTINUE USE OF THE CYCLER AND TO NOTIFY THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) OF THE EVENT. A REPLACEMENT CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PATIENT CONFIRMED THAT THERE WERE NO ADVERSE EVENTS OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED TREATMENT. THE CYCLER WAS RETURNED TO THE MANUFACTURER AND A REPLACEMENT CYCLER WAS PROVIDED AND RECEIVED. UPON PHYSICAL EVALUATION OF THE CYCLER BY THE MANUFACTURER, IT WAS IDENTIFIED THAT THE TRANSFORMER ON THE INVERTER BOARD HAD AN INTERNAL SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040497 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 DELFLEX PD FLUID| LIBERTY CYCLER SET